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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 5, 1982 to May 19, 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted equivalent to OECD Guideline 402, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl carbamate
EC Number:
209-939-2
EC Name:
Methyl carbamate
Cas Number:
598-55-0
Molecular formula:
C2H5NO2
IUPAC Name:
methyl carbamate
Test material form:
other: Solid

Test animals

Species:
rabbit
Strain:
other: Albino New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2 - 3 Kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care andUse of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne rabbit ration, ad libitum
- Water: Fresh tap water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30 to 70%
- Photoperiod: 12 h dark and 12 h light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Remarks:
Test substance was only moistened with physiological saline
Details on dermal exposure:
DERMAL EXPOSURE
24 h prior to testing, fur from the trunk of the animals was shaved. Immediately prior to dosing, the skin of the rabbits was abraded by making four epidermal incisions with a clean needle through the stratum corneum, but not deep enough to disturb the derma or produce bleeding. The test substance was applied directly onto the exposed skin of the animals taking care to spread the substance evenly over the entire abraded area.

TEST SITE
- Area of exposure: 10% of of the dorsal body surface area
- Type of wrap if used: The animals were wrapped with rubber dam and an ace bandage to retard evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 h of exposure, the rubber dam and ace bandage were removed and the test site was wiped to remove any remaining material

TEST MATERIAL
- Amount(s) applied: 2,000 mg/kg bw

VEHICLE
Test substance was used as received (moistened with physiological saline).

Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: 2 and 4 h after the 24 h period of exposure, and twice daily thereafter for 14 d.
- Necropsy of survivors performed: Rabbits were sacrificed by CO2 inhalation on Day 14 and a gross necropsy was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
Slight erythema was visible on Day 1 and 2 of the study.
Gross pathology:
Terminal necropsy revealed no visible lesions in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test substance for male and female rabbits was determined to be ≥2,000 mg/kg bw.
Executive summary:

A study was conducted to assess the acute dermal toxicity of the test substance on rabbits in equivalent to OECD Guideline 402, in compliance with GLP. Five male and five female rabbits were administered a single dose of the test substance at a level of 2,000 mg/kg bw. 24 h prior to dosing the fur from the trunk of each animal was shaved so that at least 10% of dorsal body surface area was available for test substance administration. Immediately prior to dosing, the skin of the rabbits was abraded by making four epidermal incisions with a clean needle through the stratum corneum, but not deep enough to disturb the derma or produce bleeding. Test substance was moistened with physiological saline and applied directly to abraded skin. Wrap of the rubber dam and ace bandage was used to retard evaporation. Following the 24 h exposure period, test substance was wiped off. All animals were observed at 2, 4 h interval and twice daily thereafter for 14 d. No animal died during the study. All rabbits were sacrificed by CO2 inhalation on Day 14 and a gross necropsy was performed. Only a slight erythema was visible on Day 1 and 2 of the study. No signs of edema were observed during the study. Terminal necropsy revealed no visible lesions in any of the animals. Under the study conditions, the acute dermal LD50of the test substance for male and female rabbits was determined to be ≥2,000 mg/kg bw (Mallory VT, 1982).